A very short introduction to patents & access to medicines

Generic competition has allowed drops of HIV drug pricing by 99% Source: MSF Untangling the Web of Antiretroviral Price Reductions, 15 th Edition, July 2012

Vital Importance of affordable generic medicines Today, more than 98% of PEPFAR ARV purchases are generic - Generics saved PEPFAR $380 million in 2010 alone …and more than 91% of donor-funded pediatric ARVs are generics from India MSF is highly reliant on generic medicines to provide HIV/AIDS treatment but we are not alone - More than 80% of the donor funded AIDS drugs in developing countries are generics

Prices raising for next generation HIV Drugs Source: MSF Untangling the Web of antiretroviral Price Reductions, 15 th Edition, July 2012 Demand for second-line and third-line HIV treatments is growing The most affordable second-line regimen is more than twice as expensive as the recommended first-line regimen The price of a third-line regimen is more than 14 times higher than the recommended first-line regimen

Why? Patented medicines are reaching developing countries

The world is changing 1995 World Trade Organisation (WTO) established an Agreement on Trade Related aspects of Intellectual Property Rights (TRIPS) - “minimum” standards of protection of intellectual property rights - 20 year patents on pharmaceutical products & processes 2005 TRIPS Agreement - fully implemented & medicines become patentable everywhere (except LDCs) Consequence: India and other developing countries have to start granting patents on medicines © Sven Torrfin 2011

What are Patents & how they delay access to generics medicines A patent is an exclusive legal right given by governments to exclude others from making, using, or selling a claimed invention in a country without their consent. Patents are given for a fixed period of time (WTO says - 20 years). Patents allow the creation of monopolies - When patent barriers are removed, competition between manufacturers enables production of generic medicines © Sven Torrfin 2011

Options in the current innovation system I. Differential pricing for patented medicines: Pharmaceutical voluntary discounts not steep enough and not as effective as generic competition + many middle-income economies II. ‘Voluntary’ licenses: Negotiated in secret, limited geographical scope and with restrictions that hamper effect of generic competitions by segmenting markets, trade in API... We need to carefully watch – Medicines Patent Pool trying to make a difference III. TRIPS Flexibilities: LDC 2016 / Strict Patentability Criteria & patent oppositions/ Compulsory Licensing (Others: Competition Law, Limits on Remedies …)

9 Doha Declaration “We affirm that the (TRIPS) Agreement can and should be interpreted and implemented in a manner supportive of WTO Members' right to protect public health and, in particular, to promote access to medicines for all.” WTO Ministerial Declaration on the TRIPS Agreement and Public Health November 14, 2001

Two of the TRIPS Flexibilities that REMOVE patent barriers I. Patent opposition Defensive or offensive strategy – before or after patent office has decided to grant a patent it can be challenged and (if successful) not granted Pre-grant patent oppositions usually preferable Depending on national law anybody can oppose a patent – even civil society II. Compulsory License Offensive strategy – If a patent exist, a government can authorize the manufacturing/use of generic products without the consent of patent holder/pharmaceutical company Under certain conditions. E.g. in exchange of a royalty payment + some times you have to negotiate first with patent holder Remember: First Step is to check if TRIPS flexibilities are in your national law (and if not, ask for it – Fix Patent Laws)

Patents = Monopolies = No Competition / No Generics = Higher prices © Sven Torrfin 2011 Drug not patented Drug patent Successfully Opposed Patent compulsory License granted Generic competition allowed

SUMMARY - Why ACTION is needed? Changed environment post-TRIPS - Newer products patented in developing countries – Prices will not come down automatically – IP barriers to the development of specific formulations e.g. FDC Deliberate action is needed to counter the consequences of global pharmaceutical monopolies: – Use of the TRIPS flexibilities in patent law by governments and civil society – E.g. compulsory licensing and patent oppositions

13 Thank You! Judit Rius Sanjuan MSF Access Campaign USA More Information: